Ozone-based Eye Drops as Adjuvant Therapy in Microbial Keratitis

NCT05689996 | Unknown Phase 3

• 1 other identifier: Ozone-based eye drops
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the therapeutic effect of ozone-based eye drops as an adjuvant therapy to that of the conventional topical antimicrobial agents in patients with microbial keratitis . The therapeutic response will be evaluated with clinical examination follow up .

Conditions

Keratitis

Keywords

Microbial keratitis

Outcome Measures

Primary Outcomes (1)

• Ozone-based eye drops as adjuvant therapy in microbial keratitis

  compare the therapeutic effect of ozone-based eye drops as an adjuvant therapy to that of the conventional topical antimicrobial agents in patients with microbial keratitis. Main outcome measurements include decrease in size, depth and infiltrate of the ulcer in millimeters measured on slit lamp biomicroscopy .

  at 48 hours , 2-3 weeks

Study Arms (1)

Infective keratitis

EXPERIMENTAL

Preparation of nanostructure lipid carriers (NLCs): The emulsification-solvent evaporation technique was used to prepare the NLCs. The method was followed by ultrasonication as reported \[1\]. In brief, the lipid phase was composed of stearic acid (solid lipid, 300 mg and oleic acid (liquid lipid, 300 mg) dissolved in ethanol (2 mL, 1:1, v/v) at 70oC. In total, 20 mL of the distilled water containing 2% of the Tween® 80 were heated at 70 oC to prepare the aqueous phase. Then, both phases, aqueous and lipid phases, were mixed at the same temperature using 2000 rpm stirring for 15 min. The resulting pre-emulsion obtained from the mixture of the aqueous and lipid phases was sonicated by a probe-type sonicator (Cole-Parmer, Vernon Hills, IL, USA) for 10 min at pulse-ON for 3 s and pulse-OFF for 5 s (40 W). The obtained dispersion was allowed to cool to RT under continuous stirring for 60 min at 1000 rpm for 1 h to obtain the NLCs dispersions.

Drug: Ozone-Based Agent

Interventions

Ozone-Based Agent DRUG

Ozone-based eye drops as adjuvant therapy in microbial keratitis

Also known as: ozone-based eye drops

Infective keratitis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with active microbial keratitis ( bacterial , viral or fungal )
• with positive culture and sensitivity result
• Any age group.
• accepting well informed consent for using the ozone eye drops

You may not qualify if:

• patients refuse to participate
• Patients with other forms of keratitis rather than infective keratitis . patients who will not complete treatment .

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Spadea L, Tonti E, Spaterna A, Marchegiani A. Use of Ozone-Based Eye Drops: A Series of Cases in Veterinary and Human Spontaneous Ocular Pathologies. Case Rep Ophthalmol. 2018 May 24;9(2):287-298. doi: 10.1159/000488846. eCollection 2018 May-Aug.

  PMID: 29928225 BACKGROUND

• Paduch R, Urbanik-Sypniewska T, Kutkowska J, Choragiewicz T, Matysik-Wozniak A, Zweifel S, Czarnek-Chudzik A, Zaluska W, Rejdak R, Toro MD. Ozone-Based Eye Drops Activity on Ocular Epithelial Cells and Potential Pathogens Infecting the Front of the Eye. Antioxidants (Basel). 2021 Jun 16;10(6):968. doi: 10.3390/antiox10060968.

  PMID: 34208703 BACKGROUND

• Passidomo F, Pignatelli F, Addabbo G, Costagliola C. Topical Liposomal Ozonated Oil in Complicated Corneal Disease: A Report on Three Clinical Cases. Int Med Case Rep J. 2021 May 14;14:327-332. doi: 10.2147/IMCRJ.S311839. eCollection 2021.

  PMID: 34017203 BACKGROUND

• Sridhar MS, Martin R. Anterior segment optical coherence tomography for evaluation of cornea and ocular surface. Indian J Ophthalmol. 2018 Mar;66(3):367-372. doi: 10.4103/ijo.IJO_823_17.

  PMID: 29480245 BACKGROUND

MeSH Terms

Conditions

Keratitis

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Central Study Contacts

Abeer Abdel-Fattah

CONTACT

1064464974; abeerabdelfattah1@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmology Resident, Assiut University Hospital

Model Details: Preparation of nanostructure lipid carriers (NLCs): The emulsification-solvent evaporation technique was used to prepare the NLCs. The method was followed by ultrasonication as reported \[1\]. In brief, the lipid phase was composed of stearic acid (solid lipid, 300 mg and oleic acid (liquid lipid, 300 mg) dissolved in ethanol (2 mL, 1:1, v/v) at 70oC. In total, 20 mL of the distilled water containing 2% of the Tween® 80 were heated at 70 oC to prepare the aqueous phase. Then, both phases, aqueous and lipid phases, were mixed at the same temperature using 2000 rpm stirring for 15 min. The resulting pre-emulsion obtained from the mixture of the aqueous and lipid phases was sonicated by a probe-type sonicator (Cole-Parmer, Vernon Hills, IL, USA) for 10 min at pulse-ON for 3 s and pulse-OFF for 5 s (40 W). The obtained dispersion was allowed to cool to RT under continuous stirring for 60 min at 1000 rpm for 1 h to obtain the NLCs dispersions.

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: January 19, 2023
• Study Start: January 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: January 19, 2023

Record last verified: 2023-01